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NCT Number: NCT07408674

COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.

Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial.

Participants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).

The study aims to compare the clinical outcomes of conventional provisional stenting (Angiolite in the main branch, with optional side branch stenting if compromised) versus DCB enhanced provisional stenting (Angiolite in the main branch plus Essential Pro in the side branch) in patients with complex left main bifurcation stenosis indicated to receive non-urgent percutaneous coronary intervention (PCI).

Target lesions, both main vessel and side branch, will be treated using iVascular devices, with patients randomized into two arms. In one arm, treatment will be performed exclusively with the Angiolite sirolimus-eluting stent (Angiolite, iVascular) in the main vessel, while in the other arm, the Angiolite will be used in the main vessel and the Essential Pro paclitaxel drug-eluting balloon (Essential Pro, iVascular) in the side branch. Non-target lesions may be treated with any commercially available devices according to their approved indications.

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Key information

Conditions

Complex Left Main Bifurcation Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Bifurcation Stenosis Coronary Disease Heart Diseases Left Main Coronary Artery Stenosis Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization.
  • Left main diameter ≤6.00 mm.
  • LAD and LCx diameter both >2.75 mm, evaluated by visual estimation.

Exclusion criteria

  • Subjects with ages 18 or below at the time of the procedure.
  • Female subjects who may be pregnant or breast-feeding at the time of the procedure.
  • Previous PCI of the left main bifurcation.
  • Chronic total occlusion of the LAD or LCx.
  • Trifurcating left main requiring treatment of the 3 branches.
  • LAD and LCx reference sizes are out of the sizing ranges of the used DES/DCB families.
  • In-stent restenosis as target lesion.
  • Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.
  • ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.
  • Cardiogenic shock.
  • Left ventricular ejection fraction below 35%.
  • Decision to use mechanical circulatory support for protected PCI.
  • Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).
  • Associated significant valvular disease.
  • Renal insufficiency with glomerular filtration rate (GFR) < 20.
  • Life expectancy less than one year.

Treatment and study plan

Angiolite Sirolimus-Eluting Stenting

Device

Conventional Provisional Stenting

Other names: Coronary Stent

Essential Pro Paclitaxel Drug-Eluting Balloon

Device

Drug-Coated Balloon

Other names: DBC, Drug Eluting Balloon, Drug Enhanced Balloon

Primary outcomes

  1. Angiography-based late lumen loss

    Time frame: 12 months post procedure

    Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch)

Secondary outcomes

  1. 2. Late lumen loss

    Time frame: at 12 months post procedure

    Late lumen loss at the level of proximal- and distal main branch (primarily stented branch)

  2. Stent thrombosis rate

    Time frame: at 12 months post procedure

    Stent thrombosis rate (acute, subacute, late) at 12 months.

  3. Optical coherence tomography (OCT)-based minimal stent / lumen area

    Time frame: at 12 months post procedure

    Optical coherence tomography (OCT)-based minimal stent / lumen area at the level of LM, LAD ostium and left circumflex (LCx) ostium at 12 months.

  4. OCT-based area stenosis

    Time frame: at 12 months post procedure

    OCT-based area stenosis at the level of LM, LAD ostium and LCx ostium

  5. Acute lumen gain (2D)

    Time frame: at index procedure

    Acute lumen gain based on 2D quantitative coronary angiography

  6. Acute lumen gain (3D)

    Time frame: at index procedure

    Acute lumen gain based on 3D quantitative coronary angiography

  7. Acute functional result

    Time frame: at index procedure

    Acute functional result in the LAD and in the LCx, defined by Murray law-based quantitative flow ratio (μQFR)

  8. Functional result in the LAD and in the LCx

    Time frame: at 12 months post procedure

    Functional result in the LAD and in the LCx, defined by μQFR

  9. Delta μQFR in the LAD and in the LCx

    Time frame: at index procedure and at12 months post procedure

    Delta μQFR in the LAD and in the LCx between acute (index procedure) and 12 months follow-up

  10. Malposition rate

    Time frame: at 12 months post procedure

    Malapposition rate by OCT

  11. Underexpansion rate

    Time frame: at 12 months post procedure

    Underexpansion rate by OCT

  12. Diameter stenosis

    Time frame: at 12 months post procedure

    Diameter stenosis based on quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium

  13. Area stenosis

    Time frame: at 12 months post procedure

    Area stenosis based on 3D quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium

  14. Conversion rate

    Time frame: at index procedure

    Conversion rate to double-stent technique

  15. Procedure time

    Time frame: at index procedure

    Duration of index procedure

  16. Used contrast media

    Time frame: at index procedure

    Used contrast media at index procedure

  17. Radiation dose

    Time frame: at index procedure

    Radiation dose at index procedure

  18. Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure

    Time frame: at 6 months and 12 months pos procedure

    Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure

  19. Death

    Time frame: from index procedure to 12 months post procedure

    Death upon 12 months

  20. Myocardial Infarction

    Time frame: from index procedure to 12 months post procedure

    Myocardial Infarction upon 12 months.

  21. Target vessel revascularization

    Time frame: from index procedure to 12 months post procedure

    Target vessel revascularization upon 12 months.

  22. Hospitalization for heart failure

    Time frame: from index procedure to 12 months post procedure

    Hospitalization for heart failure upon 12 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Annelena Held, PhD, MSc

CONTACT

[email protected]

+49 157 86743867

Melissa Munoz Beilis, MD

CONTACT

[email protected]

+49 176 720 75 997

Sponsors and collaborators

Lead sponsor

Rede Optimus Hospitalar SA

Network

Collaborators

  • iVascular S.L.U.

Registry information

Official study title

The COMPETE-LM Trial: A Physician-initiated Randomized Clinical Trial (RCT) Comparing Conventional Provisional Stenting With Drug-coated Balloon-enhanced Provisional Stenting for the Treatment of Complex Left Main (LM) Coronary Artery Disease.

Acronym: COMPETE-LM

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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